CAPA management

CAPA management software that does the work behind every CAPA

Ovada is an AI quality agent that moves CAPAs forward. It gathers the records, supports the investigation, follows up with owners, drafts corrective and preventive actions, and assembles the record for qualified sign-off.

  • Evidence gathered
  • Owners followed up
  • Actions drafted
  • Quality signs

Agent · CAPA management · from DEV-2026-0098

CAPA-0412
Controlled quality recordRecurring label mix-up · packaging line 2
Ready for review

Evidence gathered3 deviations · 2 batch records · SOP-PK-004 v7

Linked

Follow-up with line supervisorShift log requested · reply received

Received

Investigation summaryDrafted · every statement cited

Ready

Proposed corrective and preventive actions2 actions drafted from the evidence

Ready

Root cause and final actionsQuality leader decides

Awaiting
Quality leader signs

01 / CAPA Management

CAPAs stall between the trigger and the signature

Opening a CAPA is easy. The hard part is everything after: gathering enough evidence to understand what happened, getting input across functions, developing actions that fix the problem, and documenting the rationale for sign-off.

Where CAPA time goes

6 items
  1. 01Finding records across systems
  2. 02Reconstructing the sequence of events
  3. 03Chasing owners for missing information
  4. 04Comparing evidence with procedures
  5. 05Drafting corrective and preventive actions
  6. 06Assembling a defensible record

Your QMS stores and routes the CAPA. Ovada does more of the work required to complete it.

02 / CAPA Management

From triggered CAPA to review-ready record

  1. 01
    Receive the CAPA trigger.

    A deviation, complaint, audit finding, assignment, or system event starts the workflow.

  2. 02
    Apply the approved procedure.

    Ovada uses your CAPA procedure, evidence requirements, roles, and documentation rules.

  3. 03
    Gather the evidence.

    It retrieves related records, quality events, procedures, and prior actions.

  4. 04
    Follow up for missing inputs.

    It asks the responsible people for what is missing and records each request.

  5. 05
    Prepare the investigation and actions.

    It organizes the facts, flags open questions, and drafts proposed corrective and preventive actions.

  6. 06
    Route for qualified sign-off.

    The quality leader decides the conclusion, revises actions, and signs.

  7. 07
    Preserve the approved record.

    The CAPA, evidence, follow-up history, and signature are kept together.

03 / CAPA Management

More than a CAPA tracker

A tracker shows that a CAPA is open, who owns it, and when it is due. Ovada does the work between those status changes: it gathers evidence, coordinates follow-up, prepares documentation, and assembles the record for review.

A CAPA rarely stands alone. It may start from a deviation or a supplier issue, and its changes ripple into related procedures. Continuous quality monitoring helps catch those effects within your approved scope.

04 / CAPA Management

What qualified people continue to own

Reserved for qualified people

6 items
  1. 01Investigation conclusions
  2. 02Root-cause determinations
  3. 03Risk assessment and acceptance
  4. 04Approval of final actions
  5. 05Effectiveness decisions
  6. 06Final review and sign-off

Built for dietary supplement manufacturers and pharmaceutical CDMOs and sponsors. These are five of Ovada’s 62 skills. The ones that matter most depend on your operation. See all 62 skills.

Frequently asked questions about CAPA management software

What is CAPA management software?

CAPA management software helps teams document, route, track, and preserve corrective and preventive actions. Ovada adds an AI quality agent that does the evidence gathering, routine follow-up, and record preparation behind each CAPA.

Do we have to replace our QMS to use Ovada for CAPAs?

No. Your QMS remains the system of record. Ovada works across your connected systems to do the CAPA work and prepare the approved record for the right destination.

Can Ovada investigate a CAPA?

Ovada gathers and organizes evidence, documents the facts, flags missing or conflicting information, and prepares material for the investigation. Qualified people own the conclusions, risk decisions, final actions, and sign-off.

Can Ovada follow up with CAPA owners?

Yes. Within your approved workflow, Ovada follows up with owners and contributors for required inputs through connected channels and records each request in the CAPA history.

Does Ovada write corrective and preventive actions?

Ovada drafts proposed corrective and preventive actions from the evidence and your procedure. Authorized quality personnel review, revise, approve, and sign the final CAPA.

See Ovada at work

Move CAPA work forward before it reaches the reviewer

Bring one evidence-heavy CAPA and watch Ovada do the work leading up to sign-off.